In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
OSB Lead-Comprehensive/Linked-Registry Based Surv.
General Study Protocol Parameters
Study involve follow-up of premarket cohort (Y/N)
Detailed Study Protocol Parameters
Study Design Description
The purpose of this surveillance project, using the Society for Vascular Surgery Vascular Quality Initiative
(SVS VQI) registry, will be to obtain data that can be used to refine the selection of and treatment strategy for patients with Type B aortic dissections managed through endovascular graft repair. Data will also be evaluated to identify any signals of device-specific safety or effectiveness issues. This project will be used to establish performance goals for future studies.
Specifically, the project will evaluate the short- and long-term clinical performance of endovascular grafts for the treatment of Type B thoracic aortic dissection, following premarket approval.
This is a cohort study of patients entered into the VQI registry, treated for Type B thoracic aortic dissection. The project will be comprised of (1) a cohort of patients followed through five years post-implant procedure (this will include a sub-cohort of the 1-year cohort); and (2) a cohort of all-comers followed through one year post-implant procedure.
Study Population Description
Two surveillance arms:
a. Five (5)-year cohort: Data will be captured on a minimum of 200
chronic and 200 acute patients with Device Technical Success, and treated at centers agreeing to participate in the surveillance project through the VQI registry. Retrospective enrollment will be allowed for patients treated on or after September 10, 2013 (date of first device approval).
b. One (1)-year: Standard VQI data will be captured on all-comers to the
VQI registry during the specified enrollment period.
?Patients diagnosed with classic ?double-barrel? Type B thoracic aortic dissection and an identifiable intimal flap, with visible contrast enhancement in the false lumen that are treated with endovascular grafts at centers participating in the VQI registry.
?For the 5-year cohort, subjects will be considered enrolled in the study after arterial cut-down and introduction of the endovascular graft. Data will be collected for unsuccessfully implanted patients through their in-hospital stay.
?Medial disruption with formation of intramural hematoma/hemorrhage
?Plaque rupture leading to aortic ulceration, penetrating aortic atherosclerotic ulcer with surrounding hematoma, usually subadventitial
?Iatrogenic and traumatic dissection
Five (5)-year cohort:
The Professional Societies estimated the 5-year incidence of dissection- related mortality as 10%
for acute dissections and 15-20% for chronic dissections.
Separately for acute and chronic dissections:
Assuming a 5-year proportion of 10%, a sample size of 200 acute patients will provide 95% confidence interval width of 5.84 - 14.16 and
assuming 20% incidence of dissection-related mortality, 200 chronic patients will provide confidence interval width of 14.46 - 25.54.
Each participating manufacturer will enroll a minimum of 60 acute and
60 chronic dissection patients for the 5-year cohort treated with their
final device design. Patient enrollment will continue until 200 acute patients and 200 chronic patients are enrolled. If the total sample size of
200 patients has been reached for one arm (acute or chronic) of the 5- year surveillance arm, but an individual device has not met the 60 patients minimum required for that arm, enrollment will only continue for that specific device.
One (1)-year cohort
Patient enrollment under this cohort will begin when the thoracic endovascular aortic repair (TEVAR) forms are released and will end after
200 patients have been enrolled.
It is estimated that 10 new patients will be added to the VQI registry every month.
Case report forms within the VQI Registry.
Long term follow-up may be enhanced with claims data
in the future
Followup Visits and Length of Followup
up to five years
OSB Lead-Comprehensive/Linked-Registry Based Surv.